Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203448
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KAITLIB FE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.025MG;0.8MG | TABLET, CHEWABLE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/17/2015 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/06/2024 | SUPPL-5 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
05/06/2024 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
KAITLIB FE
TABLET, CHEWABLE;ORAL; 0.025MG;0.8MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KAITLIB FE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.025MG;0.8MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 203448 | LUPIN LTD |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.025MG;0.8MG | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 022573 | TEVA BRANDED PHARM |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.025MG;0.8MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 203371 | XIROMED |